Brief: Autolus Therapeutics PLC Says FDA Is Not Currently Planning To Hold An Advisory Committee Meeting To Discuss Marketing Authorization Application
22/01/2024 12:29
Jan 22 (Reuters) - Autolus Therapeutics PLC AUTL.O :
* AUTOLUS THERAPEUTICS ANNOUNCES ACCEPTANCE OF BIOLOGICS
LICENSE
APPLICATION FOR OBECABTAGENE AUTOLEUCEL (OBE-CEL) AS A POTENTIAL
TREATMENT FOR RELAPSED/REFRACTORY ADULT B-CELL ACUTE
LYMPHOBLASTIC LEUKEMIA (ALL)
* AUTOLUS THERAPEUTICS PLC - PDUFA GOAL DATE IS NOVEMBER 16,
2024
* AUTOLUS THERAPEUTICS PLC - COMPANY ON TRACK TO SUBMIT A
MARKETING AUTHORIZATION APPLICATION TO EUROPEAN MEDICINES AGENCY
(EMA) IN FIRST HALF OF 2024
* AUTOLUS THERAPEUTICS PLC - FDA IS NOT CURRENTLY PLANNING
TO HOLD
AN ADVISORY COMMITTEE MEETING TO DISCUSS THIS APPLICATION
Source text for Eikon: ID:nGNX2gRpXx
Further company coverage: AUTL.O
((Reuters.Briefs@thomsonreuters.com;))
Recent news on Autolus Therapeutics
See all newsBrief: Autolus Therapeutics PLC Unit Enters Master Service Agreement With AGC Biologics
Brief: Autolus Therapeutics Appoints Ryan Richardson To Board Of Directors
Brief: Nice Recommends Aucatzyl As A Treatment Option For Adult Patients With Lymphoblastic Leukemia
Brief: Autolus Therapeutics’ Car T Therapy Aucatzyl® (Obecabtagene Autoleucel) Granted European Marketing Authorization For Adult Patients
Brief: Autolus Therapeutics Announces Inducement Grants